Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence (PSMA BCR)

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 3

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Ga-68 labeled PSMA-11 PET

Study type

Interventional

Funder types

Other

Identifiers

NCT02918357

165510

NCI-2018-00039 (Registry Identifier)

Details and patient eligibility

About

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

Full description

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.

Enrollment

385 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histopathological proven prostate adenocarcinoma.
Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
  - PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
  - Confirmatory persistent PSA greater than 0.2 ng/mL
- Post-radiation therapy -ASTRO-Phoenix consensus definition
  - Nadir + greater than or equal to 2 ng/mL rise in PSA
Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
Age > 18.
Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

Investigational therapy for prostate cancer.
Unable to lie flat, still or tolerate a PET scan.
Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).